Avid Bioservices Inc (CDMO)

[Fire Fox]

What these open design trials do is then allow periodic release of interim data to allow off-label prescribing to begin, while the actual trials go through to completion and filing and eventual approval as combo's.

Bio. I agree. Thank you for spelling out a key advantage that will flow from open label trials (separate from the point that open label will increase SK's negotiating leverage with BPs).

As I understand it, a double-blinded study is really only needed to get the drug approved and on the market. Once you are approved, follow-up studies in other indications can be "open label".

The real point I am making is that it shows a high degree of confidence in the Sunrise results within the PPHM Mgmt. team if they are already publicly announcing that future studies will be open label.

That confidence comes from the three methods SK has for triangulating on how well Bavi is doing in the Sunrise trial:

1. Calculating how much additional Bavi "maintenance" dosing is being shipped to trial centers over and above the amount needed by each center to complete the 6 cycles of protocol dosing. Note that patients who are progression free after the initial 6 rounds of protocol dosing receive continuing Bavi maintenance dosing until they progress, so SK can calculate easily how many patients receiving Bavi are still progression free.

2. Anecdotal evidence from conversations with lead investigators.

3. First look-in data from IDMC, including delays in reaching 33% eventing.